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Webinar

A Follow-up to the Sentinel Event Alert

New ISO Tubing Connector Standards:

December 3, 2014

Hosted by The Joint Commission

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Featured Presenters

• Ronald Wyatt, M.D. (The Joint Commission)

• Thomas J. Hancock (GEDSA)

• Peggi Guenter, Ph.D., R.N., FAAN (A.S.P.E.N)

• Mike Cohen, R.Ph., M.S. (ISMP)

• Amy Wilson, R.N., M.S.N., CPHQ (Sacred Heart Hospital, Pensacola, Florida)

• Sarah Amole, R.N., M.S.N. (Sacred Heart Hospital, Pensacola, Florida)

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Webinar

A Follow-up To The Sentinel Event Alert

New ISO Tubing Connector Standards:

Ronald Wyatt, M.D. The Joint Commission

GEDSA Stay ConnectedEnteral Feeding Device Connector Changes…Introducing ENFit

December 2014

4 Step and 3 Phased Approach

• Build awareness across the facility/provider to all impacted clinicians, administrators, supply chain and support staff.

• Communicate Who, What, Where, When, Why & How Impacted

• Assess processes and protocols that may need to change• Approve product changes and prepare materials/inventory mgt• Train Clinicians and Materials/Inventory Management Staff

• Introduce new connectors into work stream to reduce tubing set misconnections and improve patient safety

• Transition & Integration into medical practice

• Measure teams ability to adopt changes and reassess how to improve the process for next phase

• Post execution monitoring, metrics, feedback processes

AWARE

PREPARE

ADOPT

MEASURE

Stayconnected2015.org

3 Phases of Delivery System Launches

Q1’14 Q2’14 Q3’14 Q4’14 Q1’15 Q2’15 Q3’15 Q4’15

AWAREAwareness Campaign

PREPAREIn-Service &

Webinars

ADOPTProduct Launch

& Implementation

MEASUREAdoption & Adherence

Q4’14 Q1’15 Q2’15 Q3’15 Q4’15 Q1’16 Q2’16 Q3’16

AWAREAwareness Campaign

PREPAREIn-Service &

Webinars

ADOPTProduct Launch & Implementation

MEASUREAdoption & Adherence

Q3’15 Q4’15 Q1’16 Q2’16 Q3’16 Q4’16 Q1’17 Q2’17

AWAREAwareness Campaign

PREPAREIn-Service &

Webinars

ADOPTProduct Launch &

Implementation

MEASUREAdoption & Adherence

PHASE I - Enteral

PHASE II - Neuraxial

PHASE III – Therapeutic Family TBD

Stayconnected2015.org

Nutrition End Connector

• Introduced in 2012

• Adopted across the market by enteral industry

• Prevents inadvertent use of IV tubing as an administration set.

• Will be an ISO 18250 Standard for reservoir connectors

FROM

TO

Stayconnected2015.org

The Challenge…Connecting a System Designed Not to Connect

CURRENT NEW

Male Stepped or “Christmas Tree” Connector from

Administration Set

Female Feeding Tube Port

Female ENFit Connector from

Administration Set

Male ENFit Connector for Feeding Tube

Stayconnected2015.org

ENFit Transition Connector

Temporary Transition NEWCurrent

Female ENFitConnector from

Administration Set

FemaleFeeding Tube

Port

Transition Connector

Stayconnected2015.org

US Enteral Patient Access Estimated Launch Timelines

TransitionSet Launch

New SyringeLaunch

LaunchISO Tubes

Oct‘14

Dec ’14

Jan‘15

Feb ‘15

Mar ‘15

Apr ’15

May‘15

June‘14

July‘15

Sep’15

Jan‘16

Trasition Set Rampdown

CADeadline

Stayconnected2015.org

ENFit Transition Connector

• Allows fitment to current feeding ports until new enteral feeding tubes are available.

• Available Q1 2015 in all administration set.

• Used during year of transition.

Stayconnected2015.org

Enteral Syringes with ENFit Connectors

• Syringes to administer medicine, flushes, supplemental hydration, or bolus feeding through the enteral tubes.

• Will now require this Enteral Specific syringe with ENFit female connector

• Oral, Luer or cath-tip syringe will no longer fit

• Available Q2 - 2015

Stayconnected2015.org

ENFit Feeding Tube• Reversed orientation from female

to male port

• Locking & forcing function features

• All enteral and multi-purpose ports must have ENFit connector

• Available Q3 2015

Stayconnected2015.org

©2014 Novation Confidential.14 Stayconnected2015.org

Preparing for Change

• Concerns: Distribution, Adoption, Conversion and Compatibility• Ordering and Stocking of Supplies• Supplier Part Numbers• Adopt the new devices

• Patient transfers between facilities or healthcare systems• Prepare and avoid potential delays in healthcare services• New staff orientation and education to devices

©2014 Novation Confidential.15 Stayconnected2015.org

Recommendations

• Begin familiarizing your organization with the new standards• Develop an interdisciplinary team and begin discussions

about new standards• Utilize resources available to help prepare for change

• Transition checklist• 2013 Healthcare Supply Chain Expo Panel Discussion • Raising Awareness Webinar by Peggi Guenter of ASPEN• FAQs

Stay Connected Communications Initiative

• Global communications program to introducenew standard connectors

• Four phases—Aware, Prepare, Adopt & Measureto facilitate the transition

• Improve patient safety by reducing the risk of medical device tubing misconnections

• Starting in 2014 with enteral devices• Eventually introduce new standard connectors for specific delivery

systems including neuraxial, limb cuff inflation, and respiratory applications

• www.StayConnected2015.org

PREPARE Checklists

GEDSA Members2014/2015 Members

• Abbott

• AbbVie

• A. Hopf

• Alcor Scientific

• Amsino

• Baxter

• B Braun

• BD

• Boston Scientific

• Cair Lgl

• Cedic/Entek

• Cook Medical

• Corpak

• Covidien

• Dale Medical

• Degania

• Enteral UK

• Fresenius Kabi

• Kimberly Clark

• Medela

• Medicina

• Medline

• Moog

• NeoMed

• Nestle

• Nutricia

• Smith’s Medical

• Vygon

• Xeridiem

• VR Medical

Evaluating

• AMT

• Bard

• ConMed

• Footprint Medical

• Hospira

• JMS

• NeoChild

• Philip's

• Pajunk

• Teleflex

• Utah Medical

• Value Plastics (Nordson Med)

Stay Connected Driven by Industry, Supply Chain, Clinician & Patient Partnership Developed by Global Enteral Device Supplier Association (GEDSA) in partnership with experts from leading industry organizations

Getting Prepared: New Enteral Connectors

Peggi Guenter, PhD, RN, FAAN Senior Director for Clinical Practice, Quality, and AdvocacyAmerican Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)Silver Spring, MD

What is a Small-bore Connector (SBC)?A small-bore connector is a

connector with • an inner diameter of less

than 8.5 mm • used to link or join

medical devices, components, and accessories

• for the purpose of delivering fluids or gases.

A Luer connector is a classic type of a small-bore connector used commonly in the healthcare setting-a universal connector.

? Central Venous Catheter

? Gastrostomy Tube ?Arterial Catheter

? Epidural Catheter

2/7/00

Enteral Misconnection

Definition: An inadvertent connection between an enteral feeding system and a non-enteral system such as an intravascular catheter, peritoneal dialysis catheter, tracheostomy, medical gas tubing,etc.

Also known as a wrong route error or small bore misconnection

Guenter et al. The Joint Commission Journal on Quality and Patient Safety May 2008;34:285-292.

Impact of MisconnectionsA 24-year-old woman was 35 weeks pregnant hospitalized for vomiting and dehydration. A bag of ready

to hang enteral feeding was brought to the floor, and the nurse, assuming it was total parenteral nutrition, which the woman had received on previous admissions, pulled regular intravenous tubing from floor stock, spiked the bag, and started the infusion of tube feeding through the patient’s peripherally inserted central catheter line. The fetus died—and then the mother. Guenter et al. The Joint Commission Journal on Quality and Patient Safety May 2008;34:285-292.

Following a routine carpal tunnel surgical procedure, a PACU nurse hooked the BP monitor to the patients IV which caused an air embolus and killed the patient. The patients’ daughter was a PACU nurse at a different facility.

Misconnections: Two Sets of Victims

In all of these misconnections reports, there are two sets of victims, the patient and family, and the clinician involved. Clinicians never mean to make these mistakes, but they do- because they can.

Enteral Misconnection- How Can this Happen?

Obvious Not so obvious

FDA Medical Device Safety Calendar, 2009

Enteral Misconnections: Contributing Factors

Human Factors• Healthcare clinician fatigue• Distraction • Lighting

Physical and Design Factors – Compatible tubing between unlike systems– Luer connectors– Use of IV syringes for oral meds– Universal Spike for bags

Enteral Misconnection Events and Alerts

Enteral Misconnections: Published Cases

116 published cases as of 2011Like most errors, highly under-reported

Recent Event

Reported Enteral Misconnections and Related Factors

(Jan. 2000–Dec. 2006 USP data)

Guenter et al. The Joint Commission Journal on Quality and Patient Safety (2008).

Enteral Misconnections: Points of Concern

Enteral Misconnections: What About Color?

• Manufacturers have introduced color to try to trigger clinicians to prevent misconnections.

• However, color does not prevent the misconnection.

• Colors are not standardized across device types.

• May have a green connector for an EN device, an IV device, and a respiratory device so this defeats the purpose of color

• Color is not required in the new connector standard

Enteral Nutrition Connector Call for Design Changes

• Product manufacturers are urged to implement “incompatibility by design” features. 1

• “Forcing function” design changes would make incorrect connections impossible.

• A physical barrier is the most effective preventive tool when inappropriate connections are attempted.

• The entire line of connections must be unique to prevent mistakes in connection.

The Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence. March 27, 2006.

Mike CohenInstitute for Safe Medication Practices

Process Issues

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• Once new connectors are in place, unit doses of liquid medications for patients with feeding tubes can no longer be prepared or administered using an oral syringe

• We are strongly recommending that patient specific doses be prepared– Meds should be properly labeled and bar-coded for bedside

scanning– Good communication methods between pharmacy and

patient care areas is critical (which patients have feeding tubes vs. needing oral liquids for other reasons)?

– Prescribers should include “via feeding tube” in orders

Process Issues

Process Issues

• Bottle adapters to fill liquid ENFit syringes– Screw on, snap in, and Christmas Tree-type adapters are

available for use with oral syringes. A new adapter for ENFit syringes will also be available.

• Caps for syringes are also going to be available so the new ENFit syringes can be easily transported

• Other means of dispensing liquids for feeding tubes – If pharmacy does dispense liquid unit dose cups for nurses,

the new syringes can be used to prepare at bedside – but not recommended, won’t be labeled and won’t have a bar code. Cannot easily rely on bottles of liquids.

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• Unintended consequences - Possibility of jury-rigging

• Can ENFit syringe be used for all unit dose liquids?• What else will syringes be needed for?

– Flushing– Supplemental hydration– Bolus feeding

• Reinforce purpose of change. Continue to make staff aware of the transition to new enteral connectors. Initiative will enhance patient safety by reducing the risk of harmful tubing/catheter misconnections

Unresolved Process Dilemmas

• Assign individual or subgroup of implementation team to stay updated and share transition updates with the full team. Maintain regular contact – Stay Connected. The Global Enteral Device Supplier

Association (GEDSA), the coalition formed to help introduce new medical device connectors, maintains a Stay Connected website (www.stayconnected2015.org/) to keep healthcare providers up-to-date. Email notifications are available when new information has been posted.

– ISMP. We will provide regular updates impacting enteral connector transition (e.g., availability of caps, bottle adapters, educational programs) (www.ismp.org).

– Purchasers/suppliers. Stay in the loop to receive notifications and other information provided by purchasers and suppliers as the transition moves forward.

• http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=86

Stay Updated

Amy D. Wilson, RN, MSN, CPHQChief Operating Officer, Chief Nursing Officer

Sarah Amole, RN, MSNPatient Care Manager - Oncology

Sacred Heart Hospital Pensacola

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Tubing misconnections continue to cause severe patient injury and death, since tubes with different functions can easily be connected using luer connectors, or connections can be “rigged” (constructed) using adapters, tubing or catheters.

New ISO (International Organization for Standardization) tubing connector standards are being developed for manufacturers.

Involves phased implementation of redesigned tubing connectors for: Intravascular or hypodermic applications (luer connectors will be

maintained) Limb cuff inflation applications Enteral applications

The first new ISO connector standard (ANSI/AAMI/ISO 80369-1) has already been adopted and it is anticipated that the new connectors will begin to reach the market as early as the 4th quarter 2014.

Enteral Connectors will be introduced first.

Background

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Assessment of Current State / Risk MitigationConduct a risk assessment of all tubing connections

(Connections Portfolio – Tubing Misconnections Self Assessment for Health Care Facilities, ISMP and Baxter)

Implement best practice measures to mitigate the risk of inadvertent tubing misconnections

Educate staff about the risk of inadvertent tubing misconnections

Ensure a culture of safety and high reliability practicesDevelop a plan to comply with the new ISO standards

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Step One - Research the standard and supporting literature to familiarize yourself with the how’s and why’s of the change. The Joint Commission Sentinel Event Alert lists

multiple resources for planning and implementation.

www.jointcommission.org

www.StayConnected2014.org

Steps to Success

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Step Two – Identify key stakeholders from affected facilities and departments and create a core team to plan for and communicate the change. Nursing (Adult, Pediatric, Outpatient, Long Term Care)

Purchasing / Supply Chain

Distribution, Materials and Management

Pharmacy

Education

Vendor

Steps to Success

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Step Three – Perform a Gap Analysis to identify existing deviations and opportunities. List the overall strategic goal or initiative

Identify the current state of practice (list all departments and individual equipment pieces used - make no assumptions)

List each deficiency/opportunity identified

Create an action plan for each identified deficiency/opportunity to bring it from current state to goal.

Steps to Success

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Step Four – Follow through on the Gap Analysis and action plan with the team and have regular meetings to stay on track and ensure progress. Proactive approach with realistic deadlines

Engage with the vendor to ensure appropriate crosswalk of supplies

Troubleshoot barriers as they arise

Get Hands-On with any new equipment as soon as possible

Formulate an education plan and plan for follow up after implementation

Steps to Success

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Based on our product manufacturer, we do not anticipate availability of the new products until January

Online education module – all nursing staff

Hands on and Return Demonstration Competency –all nursing staff

Incorporate into Orientation for all New Hires after the roll out

Continue Safety Culture and High Reliability work

Education Plan

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Step Five – Follow up after implementation to ensure safety and success Round to ensure compliance and understanding

Track and report any issues

Continually review the ISO standards, engage with the vendors, and review best practices to mitigate inadvertent tubing misconnections.

Steps to Success

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References The Joint Commission: Managing risk during the transition to new ISO tubing connector

standards, Sentinel Event Alert #53, August 20, 2014 (accessed September 5, 2014) Small bore connectors standards development timeline, Stay Connected 2014 website,

http://www.stayconnected2014.org/#meet (accessed September 18, 2014) Connections Portfolio: Tubing misconnections self-assessment for healthcare facilities,

ISMP and Baxter, http://www.baxter.com/downloads/healthcare_professionals/clinical_center_of_excellence/baxterselfassessment.pdf (accessed September 18, 2014)

Executive Insights on Healthcare Technology Safety: See section on “Luer Connectors”and in the online Report Resources. AAMI and ECRI Institute, June 2014, http://www.aami.org/aami-ecri/Tech%20Trends%202014.pdf (accessed September 18, 2014)

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Q&A

On The Line To Answer Questions:• Ronald Wyatt, M.D. (The Joint Commission)

• Thomas J. Hancock (GEDSA)

• Peggi Guenter, Ph.D., R.N., FAAN (A.S.P.E.N)

• Mike Cohen, R.Ph., M.S. (ISMP)

• Amy Wilson, R.N., M.S.N., CPHQ (Sacred Heart Hospital, Pensacola, Florida)

• Sarah Amole, R.N., M.S.N. (Sacred Heart Hospital, Pensacola, Florida)